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Not yet recruitingNCT07084688Updated Jul 24, 2025

Swiss Cardiovascular-Kidney-Liver-Metabolic (CKLM) Registry

An observational study in Cradiovascular-kidney-liver-metabolic (CKLM) Syndrome and Cardiovascular-kidney-metabolic Syndrome, sponsored by University Hospital, Basel, Switzerland. Not yet recruiting at 1 site in Switzerland. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-07-24.

Primary conditionnone(registry's first term: Syndrome)No conditionIs this wrong?Syndrome describes something many studies share rather than a condition a study is about. The study names no condition we can place it under, so it is not compared with other studies by condition.

Sponsored by University Hospital, Basel, Switzerland · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
1,500
Ages
18 Years and older
Sex
All
01

Study summary

The aim of this clinical and exploratory Swiss Cardiovascular-Kidney-Liver-Metabolic (CKLM) Registry is to establish high quality prevalence and incidence database for Cardiovascular-Kidney-Metabolic (CKM) syndrome, its major contributors, and the extent of the respective organ damaged.

Read the detailed description

The Swiss Cardiovascular-Kidney-Liver-Metabolic (CKLM) Registry is a prospective, longitudinal, non-interventional registry based at the Medical Outpatient Department of the University Hospital Basel. It aims to address key knowledge gaps related to (I) the prevalence, incidence, and heterogeneity of CKLM syndrome and its clinical phenotypes, (II) liver involvement, (III) emerging therapies, and (IV) the need for interdisciplinary care and integrated management. The registry supports improved understanding and management of this complex syndrome in routine clinical practice.

02

Conditions studied

  • Cradiovascular-kidney-liver-metabolic (CKLM) Syndrome
  • Cardiovascular-kidney-metabolic Syndrome

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Keywords

  • Cardiovascular-kidney-liver-metabolic (CKLM) syndrome
  • Cardiovascular disease (CVD)
  • Chronic kidney disease (CKD)
  • Organ-specific diseases
  • Cardiovascular-kidney-metabolic (CKM) syndrome
03

In context

Lead sponsor

University Hospital, Basel, Switzerland is the lead sponsor of 990 studies on the registry; 189 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
Yes
Sampling method
Probability sample

Study population

Approximately 200-300 participants with cardiovascular-kidney-metabolic (CKM) syndrome per year at the Medical Outpatient Department of the University Hospital Basel

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • At least 18 years of age
  • Individuals diagnosed with cardiovascular-kidney-metabolic (CKM) syndrome stages 0 to 3 according to the American Heart Association (AHA) or liver disease defined by any of the following:

    • For stage 0: Individuals without overweight/obesity, metabolic risk factors (normoglycemia, normotension, normal lipid profile), Chronic kidney disease (CKD), or Cardiovascular disease (CVD)
    • Individuals with overweight/obesity or dysfunctional adipose tissue, without other metabolic risk factors or CKD
    • Individuals with metabolic risk factors (hypertriglyceridemia, arterial hypertension, metabolic syndrome, diabetes) or CKD
    • Subclinical Atherosclerotic cardiovascular disease (ASCVD) or subclinical heart failure (HF) in individuals with excess/dysfunctional adiposity, other metabolic risk factors, or CKD in the clinical assessment[2]
    • Independent of CKM syndrome stages, individual with signs of hepatic steatosis on imaging
  • Willingness to provide

Exclusion criteria

Exclusion Criteria:

  • Individuals with CKM syndrome stage 4 according to the AHA

    * Individuals with clinical cardiovascular disease including:

    • History of coronary artery disease, myocardial infarction, coronary artery intervention
    • History of atrial fibrillation
    • History of stroke
    • Symptomatic peripheral artery disease (>stage I)
    • History of symptomatic HF
    • History of HF hospitalisation
  • Inability to sign
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

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Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
1,500 participants (estimated)
Target follow-up
10 Years
Patient registry
Yes
06

What researchers measure

Primary outcomes

  1. Frequency of cardiovascular diseases

    Out of available clinical data from the local electronic health record the frequency of cardiovascular diseases (e.g. stroke, myocardial infarction, coronary artery disease, peripheral arterial disease, hypertension, heart failure) will be assessed

    Time frame: At baseline, 6, 12 months and annually up to 10 years

  2. Frequency of kidney diseases

    Out of available clinical data from the local electronic health record the frequency of kidney diseases (e.g. chronic kidney disease, kidney failure) will be assessed

    Time frame: At baseline, 6, 12 months and annually up to 10 years

  3. Frequency of liver diseases

    Out of available clinical data from the local electronic health record the frequency of liver diseases (e.g. Metabolic Dysfunction-associated steatotic liver disease, MASLD) will be assessed

    Time frame: At baseline, 6, 12 months and annually up to 10 years

  4. Frequency of metabolic diseases

    Out of available clinical data from the local electronic health record the frequency of metabolic diseases (e.g. dyslipidemia, pre-/diabetes) will be assessed

    Time frame: At baseline, 6, 12 months and annually up to 10 years

  5. Frequency of microalbuminuria

    Frequency of microalbuminuria

    Time frame: At baseline, 6, 12 months and annually up to 5 years

  6. Frequency of increased HbA1c

    Frequency of increased HbA1c

    Time frame: At baseline, 6, 12 months and annually up to 5 years

  7. Assessment of Fib4-score

    Assessment of Fib-4 score

    Time frame: At baseline, 6, 12 months and annually up to 5 years

  8. Signs of hypertensive heart disease

    Signs of hypertensive heart disease at transthoracic echocardiography determined by left ventricular hypertrophy (LVH)

    Time frame: At baseline, 6, 12 months and annually up to 10 years

  9. Signs of steatosis hepatis

    Signs of steatosis hepatis in abdominal sonography defined as increased liver echogenicity

    Time frame: At baseline, 6, 12 months and annually up to 5 years

  10. Structured, registry specific questionnaire

    The structured questionnaire is register-specifically designed and focuses on questions related to health behavior, medical history, mental health disorders, social determinants of health and adverse events. The collected data are aggregated to allow for standardized evaluation of key domains across the study population.

    Time frame: At baseline and annually up to 10 years

  11. EQ-5D-5L

    Assessment of quality of life with the EQ-5D-5L ( (European Quality of Life 5 Dimensions 5 Level Version) tool within the study specific questionaire. 5 Dimensions of quality of life will be asked and coded in a 1-digit number that describes health state. Higher 1-digit numbers indicate a worse outcome. The tool also includes a EQ visual analogue scale (VAS), a quantitative and subjective measure of health outcome. Higher values indicate a better outcome.

    Time frame: At baseline and annually up to 10 years

07

Study locations

1 site
  • Medical Outpatient Department of the University Hospital Basel
    Basel, Canton of Basel-City 4031, Switzerland
    • Annina Vischer, PD Dr. med. · Contactannina.vischer@usb.ch · 0041613286630
    • Annina Vischer, PD Dr. med. · Principal investigator
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 24, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT07084688
Responsible party
Sponsor
First posted
Jul 24, 2025
Start date
Jul 14, 2025 (estimated)
Primary completion
Jul 2040 (estimated)
Completion
Jul 2040 (estimated)
Last update
Jul 24, 2025

Study contacts

Annina Vischer, PD Dr. med.
Contact
annina.vischer@usb.ch
0041613286630
Thilo Burkard, PD Dr. med.
Contact
thilo.burkard@usb.ch
0041613287738
Annina Vischer, PD Dr. med.
principal investigator · Medical Outpatient Department and Hypertension Clinic, ESH Hypertension Centre of Excellence, University Hospital Basel

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Jul 2025. You cannot join it, but the record below documents what was studied.

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